Prolapse prevention device and methods of use thereof

ABSTRACT

A prolapse prevention device formed by a continuous wire-like structure having a first end and a second end disconnected from each other. The continuous wire-like structure of the prolapse prevention device is substantially straight in a delivery configuration. The prolapse prevention device in a deployed configuration includes a centering ring of the continuous wire-like structure configured to seat adjacent to and upstream of an annulus of a heart valve in situ, a vertical support of the continuous wire-like structure which extends from the centering ring and includes an apex configured to seat against a roof of an atrium in situ, and a leaflet backstop of the continuous wire-like structure extending radially inward from the centering ring and configured to contact at least at least a first leaflet of the heart valve in situ to exert a pressure in a downstream direction on the first leaflet to prevent the first leaflet from prolapsing into the atrium.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/645,307, filed Mar. 20, 2018, which is herebyincorporated by reference in its entirety for all purposes.

FIELD OF THE INVENTION

The present technology relates generally to devices for repairing avalve suffering from regurgitation, and associated systems and methods.

BACKGROUND OF THE INVENTION

The human heart is a four chambered, muscular organ that provides bloodcirculation through the body during a cardiac cycle. The four mainchambers include the right atrium and right ventricle which supplies thepulmonary circulation, and the left atrium and left ventricle whichsupplies oxygenated blood received from the lungs to the remaining body.To ensure that blood flows in one direction through the heart,atrioventricular valves (tricuspid and mitral valves) are presentbetween the junctions of the atrium and the ventricles, and semi-lunarvalves (pulmonary valve and aortic valve) govern the exits of theventricles leading to the lungs and the rest of the body. These valvescontain leaflets or cusps that open and shut in response to bloodpressure changes caused by the contraction and relaxation of the heartchambers. The leaflets move apart from each other to open and allowblood to flow downstream of the valve, and coapt to close and preventbackflow or regurgitation in an upstream manner.

The mitral valve, also known as the bicuspid or left atrioventricularvalve, is a dual flap valve located between the left atrium and the leftventricle. The mitral valve serves to direct oxygenated blood from thelungs through the left side of the heart and into the aorta fordistribution to the body. As with other valves of the heart, the mitralvalve is a passive structure in that does not itself expend any energyand does not perform any active contractile function. The mitral valveincludes two moveable leaflets, an anterior leaflet and a posteriorleaflet, that each open and close in response to differential pressureson either side of the valve. Ideally, the leaflets move apart from eachother when the valve is in an open configuration and meet or “coapt”when the valve is in a closed configuration.

Diseases associated with heart valves, such as those caused by damage ora defect, can include stenosis and valvular insufficiency orregurgitation. These diseases can occur individually or concomitantly inthe same valve. Valvular insufficiency or regurgitation occurs when thevalve does not close completely, allowing blood to flow backwards,thereby causing the heart to be less efficient. A diseased or damagedvalve, which can be congenital, age-related, drug-induced, or in someinstances, caused by infection, can result in an enlarged, thickenedheart that loses elasticity and efficiency. Some symptoms of heart valvediseases can include weakness, shortness of breath, dizziness, fainting,palpitations, anemia and edema, and blood clots which can increase thelikelihood of stroke or pulmonary embolism. Symptoms can often be severeenough to be debilitating and/or life threatening.

In particular, a large portion or percentage of degenerativeregurgitation in a mitral valve is caused by a prolapsed posteriormitral leaflet. This can be caused by weakening or separation of thechordae attached to the posterior leaflet. In such cases, when themitral valve is in the closed configuration, the posterior mitralleaflet billows or bulges like a sail or a parachute into the leftatrium, causing the posterior leaflet to not fully coapt with theanterior mitral leaflet.

Currently, treatment options for the repair of a prolapsing leafletincludes re-sectioning of the prolapsed tissue, chordae repair,foldoplasty, annuloplasty, placement of a new valve, or attachment of aclip to couple a free end of the prolapsing leaflet to a free end of anon-prolapsing leaflet. However, these solutions have significantdrawbacks in terms of efficacy, safety or likelihood of complications,invasiveness, reduction in the cross-sectional area for blood flowthrough the valve, and the availability of the valve for futuretreatments.

Accordingly, there is a need for devices that can repair a valvesuffering from regurgitation due to a prolapsing leaflet more easily,with greater efficacy and fewer complications.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof are directed to an implantable prosthesis, referredto herein as a prolapse prevention device, for treating a regurgitatingheart valve. In an embodiment, the prolapse prevention device is formedby a continuous wire-like structure having a first end and a second endthat opposes the first end, the first end and the second end beingdisconnected from each other. The continuous wire-like structure of theprolapse prevention device is substantially straight in a deliveryconfiguration. The continuous wire-like structure of the prolapseprevention device in a deployed configuration includes a centering ringconfigured to seat adjacent to and upstream of an annulus of a heartvalve to circumferentially center the prolapse prevention device insitu, a vertical support extending from the centering ring such that anapex thereof is configured to seat against a roof of the atrium in situ,and a leaflet backstop extending radially inward from the centering ringand configured to contact at least a first leaflet of the heart valve insitu to exert a pressure in a downstream direction on the first leafletto prevent the first leaflet from prolapsing into the atrium.

In another embodiment, the prolapse prevention device is formed by acontinuous wire-like structure having a first end and a second end thatopposes the first end, the first end and the second end beingdisconnected from each other. The prolapse prevention device in adeployed configuration includes a centering ring configured to seatadjacent to and upstream of an annulus of a heart valve tocircumferentially center the prolapse prevention device in situ. Thecentering ring is an open ring. The prolapse prevention device in thedeployed configuration further includes an inner tail that conforms toan inner surface of the centering ring and is configured to permit theopen ring to self-adjust to a size of the annulus of the heart valve.The prolapse prevention device in the deployed configuration furtherincludes a leaflet backstop extending radially inward from the centeringring and configured to contact at least a first leaflet of the heartvalve in situ to exert a pressure in a downstream direction on the firstleaflet to prevent the first leaflet from prolapsing into the atrium, avertical support extending from the centering ring in an upstreamdirection such that an apex thereof is configured to seat against a roofof an atrium in situ, and a retrieval arm extending from the apex of thevertical support in a downstream direction, away from the roof of theatrium.

Embodiments hereof are also directed to methods of treating heartvalvular regurgitation with a system including a delivery catheter and aprolapse prevention device. More particularly, the system ispercutaneously introduced into a vasculature. The system is deliveredthrough the vasculature to a heart valve with the prolapse preventiondevice in a delivery configuration. The prolapse prevention device isformed by a continuous wire-like structure having a first end and asecond end that opposes the first end, the first end and the second endbeing disconnected from each other. The continuous wire-like structureis substantially straight when the prolapse prevention device is in thedelivery configuration. A distal end of the delivery catheter ispositioned adjacent to an annulus of a heart valve. The prolapseprevention device is deployed such that a centering ring of thecontinuous wire-like structure is seated adjacent to and upstream of theannulus of the heart valve, a vertical support of the continuouswire-like structure extends from the centering ring and an apex thereofis seated against a roof of the atrium, and a leaflet backstop of thecontinuous wire-like structure is extending radially inward from thecentering ring and contacts at least a first leaflet of the heart valveto exert a pressure in a downstream direction on the first leaflet toprevent the first leaflet from prolapsing into the atrium.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and aspects of the present technologycan be better understood from the following description of embodimentsand as illustrated in the accompanying drawings. The accompanyingdrawings, which are incorporated herein and form a part of thespecification, further serve to illustrate the principles of the presenttechnology. The components in the drawings are not necessarily to scale.

FIG. 1 is a schematic sectional illustration of a mammalian heart havingnative valve structures.

FIG. 2A is a schematic sectional illustration of a left ventricle of amammalian heart showing anatomical structures and a native mitral valve.

FIG. 2B is a schematic sectional illustration of the left ventricle of aheart having a prolapsed mitral valve in which the leaflets do notsufficiently coapt and which is suitable for repair with a device inaccordance with embodiments hereof.

FIG. 2C is a schematic sectional illustration of the left ventricle ofFIG. 2B as viewed from a different angle.

FIG. 2D is a top view illustration of the prolapsed mitral valve of FIG.2B, wherein the mitral valve is in an open configuration.

FIG. 2E is a schematic illustration of a superior view a mitral valveisolated from the surrounding heart structures and showing the annulusand native leaflets.

FIG. 2F is a schematic illustration of a superior view a mitral valve,aortic mitral curtain and portions of the aortic valve isolated from thesurrounding heart structures and showing regions of the native mitralvalve leaflets.

FIG. 3 is a perspective illustration of a prolapse prevention device fortreating heart valvular regurgitation in accordance with an embodimenthereof, wherein the prolapse prevention device is shown in its deployedconfiguration.

FIG. 4 is a side view of the prolapse prevention device of FIG. 3.

FIG. 5 is a perspective illustration of a prolapse prevention device fortreating heart valvular regurgitation in accordance with anotherembodiment hereof, wherein a leaflet backstop of the prolapse preventiondevice has a wavy configuration.

FIG. 6 is a perspective illustration of a prolapse prevention device fortreating heart valvular regurgitation in accordance with anotherembodiment hereof, wherein a leaflet backstop of the prolapse preventiondevice has a partial ring configuration.

FIG. 7 is a perspective illustration of a prolapse prevention device fortreating heart valvular regurgitation in accordance with anotherembodiment hereof, wherein a vertical support of the prolapse preventiondevice includes a sinusoidal portion.

FIG. 8 is a perspective illustration of a prolapse prevention device fortreating heart valvular regurgitation in accordance with anotherembodiment hereof, wherein the vertical support of the prolapseprevention device is curved to be configured to abut against a sidewallof the left atrium of the heart.

FIG. 9 is a side view illustration of a delivery catheter for deliveringthe prolapse prevention device according to an embodiment hereof,wherein the prolapse prevention device of FIG. 3 is shown disposedwithin the delivery catheter in a delivery configuration.

FIG. 10 is a sectional cut-away illustration of a heart illustrating amethod step of using the prolapse prevention device of FIG. 3 to repaira prolapsed posterior leaflet of a mitral valve using a transseptalapproach in accordance with an embodiment hereof, wherein the deliverycatheter of FIG. 9 is positioned within the left atrium of the heart andincludes the prolapse prevention device of FIG. 3 in the deliveryconfiguration disposed therein.

FIG. 11 is a sectional cut-away illustration of the heart illustrating amethod step of using the prolapse prevention device of FIG. 3 to repairthe prolapsed posterior leaflet of the mitral valve, wherein a distalend of the delivery catheter of FIG. 9 is positioned adjacent to anative mitral valve of the heart.

FIG. 12 is a sectional cut-away illustration of the heart illustrating amethod step of using the prolapse prevention device of FIG. 3 to repairthe prolapsed posterior leaflet of the mitral valve, wherein thedelivery catheter of FIG. 9 has been retracted to partially deploy theprolapse prevention device of FIG. 3.

FIG. 13 is a sectional cut-away illustration of the heart illustrating amethod step of using the prolapse prevention device of FIG. 3 to repairthe prolapsed posterior leaflet of the mitral valve, wherein thedelivery catheter of FIG. 9 has been retracted to fully deploy theprolapse prevention device of FIG. 3.

FIG. 14 is a sectional cut-away illustration of the heart illustrating amethod step of using the prolapse prevention device of FIG. 3 to repairthe prolapsed posterior leaflet of the mitral valve, wherein thedelivery catheter of FIG. 9 has been removed from the body and theprolapse prevention device of FIG. 3 remains deployed within the leftatrium of the heart in situ.

FIG. 15 is an alternative illustration of the prolapse prevention deviceof FIG. 3 deployed within the left atrium of the heart in situ.

FIG. 16 is a perspective view illustration of a heart valve prosthesisdeployed within the prolapse prevention device of FIG. 3 according to anembodiment hereof.

FIG. 17 is a perspective view illustration of a heart valve prosthesisdeployed within a prolapse prevention according to another embodimenthereof.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal”, when used in the following description to refer to adelivery device, delivery system, or delivery catheter are with respectto a position or direction relative to the treating clinician. Thus,“distal” and “distally” refer to positions distant from, or in adirection away from the treating clinician, and the terms “proximal” and“proximally” refer to positions near, or in a direction toward theclinician. The terms “distal” and “proximal”, when used in the followingdescription to refer to a system or a device to be implanted into avessel, such as a device for treating heart valvular regurgitation, areused with reference to the direction of blood flow. Thus, “distal” and“distally” refer to positions in a downstream direction with respect tothe direction of blood flow, and the terms “proximal” and “proximally”refer to positions in an upstream direction with respect to thedirection of blood flow.

The following detailed description is merely exemplary in nature and isnot intended to limit the present technology or the application and usesof the present technology. Although the description of embodimentshereof is in the context of treatment of heart valvular regurgitationand particularly in the context of treatment of regurgitation of themitral valve, the present technology may also be used in any other bodypassageways where it is deemed useful including other heart valves.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

FIGS. 1-2F will now be described to provide contextual information onvalve regurgitation. FIG. 1 is a schematic sectional illustration of amammalian heart 10 that depicts the four heart chambers (right atriumRA, right ventricle RV, left atrium LA, left ventricle LV) and nativevalve structures (tricuspid valve TV, mitral valve MV, pulmonary valvePV, aortic valve AV). FIG. 2A is a schematic sectional illustration of aleft ventricle LV of the heart 10 showing anatomical structures and anative mitral valve MV. Referring to FIGS. 1 and 2A together, the heart10 comprises the left atrium LA that receives oxygenated blood from thelungs via the pulmonary veins. The left atrium LA pumps the oxygenatedblood through the mitral valve MV and into the left ventricle LV duringventricular diastole. The left ventricle LV contracts during systole andblood flows outwardly through the aortic valve AV, into the aorta and tothe remainder of the body.

In a healthy heart, the leaflets LF of the mitral valve MV meet evenlyat the free edges or “coapt” to close and prevent back flow of bloodduring contraction of the left ventricle LV (FIG. 2A). Referring to FIG.2A, the leaflets LF attach to the surrounding heart structure via adense fibrous ring of connective tissue called an annulus AN which isdistinct from both the leaflet tissue LF as well as the adjoiningmuscular tissue of the heart wall. In general, the connective tissue atthe annulus AN is more fibrous, tougher and stronger than leaflettissue. The flexible leaflet tissue of the mitral leaflets LF areconnected to papillary muscles PM, which extend upwardly from the lowerwall of the left ventricle LV and the interventricular septum IVS, viabranching tendons called chordae tendinae CT. In a heart 10 having aprolapsed mitral valve MV in which the leaflets LF do not sufficientlycoapt or meet, as shown in FIGS. 2B-2D, leakage from the left atrium LAinto the left ventricle LV will occur through a gap GP. Severalstructural defects can cause the mitral leaflets LF to prolapse suchthat regurgitation occurs, including ruptured chordae tendinae CT,impairment of papillary muscles PM (e.g., due to ischemic heartdisease), and enlargement of the heart and/or mitral valve annulus AN(e.g., cardiomyopathy).

FIG. 2E is a superior view of a mitral valve MV isolated from thesurrounding heart structures and further illustrating the shape andrelative sizes of the mitral valve leaflets AL, PL and annulus AN. FIG.2F is a schematic illustration of a superior view a mitral valve MV,aortic mitral curtain and portions of the aortic valve AV isolated fromthe surrounding heart structures and showing regions of the nativemitral valve leaflets AL, PL. With reference to FIGS. 2E and 2Ftogether, the mitral valve MV includes an anterior leaflet AL withsegments or scallops A1, A2, and A3 that meet and oppose respectivesegments or scallops P1, P2 and P3 of a posterior leaflet PL at acoaptation line C (FIG. 2F) when closed. FIGS. 2E and 2F togetherfurther illustrate the shape and relative sizes of the leaflets AL, PLof the mitral valve. As shown, the mitral valve MV generally has a “D”or kidney-like shape and the line of coaptation C is curved or C-shaped,thereby defining a relatively large anterior leaflet AL andsubstantially smaller posterior leaflet PL. Both leaflets appeargenerally crescent-shaped from the superior or atrial side, with theanterior leaflet AL being substantially wider in the middle of the valveat the A2 segment thereof than the posterior leaflet at the P2 segmentthereof (e.g., comparing segments A2 and P2, FIG. 2F). As illustrated inFIGS. 2E and 2F, at the opposing ends of the line of coaptation C, theleaflets join together at corners called the anterolateral commissure ACand posteromedial commissure PC, respectively. When the anterior leafletAL and posterior leaflet PL fail to meet (FIG. 2E), regurgitationbetween the leaflets AL, PL or at commissures AC, PC at the cornersbetween the leaflets can occur.

With continued reference to FIGS. 2E and 2F, the mitral valve annulus ANis a fibrotic ring that consists of an anterior part and a posteriorpart. The aortic-mitral curtain (FIG. 2F) is a fibrous structure thatconnects the anterior mitral annulus AN intimately with the aortic valveannulus (at the level of the left and non-coronary cusps or sinuses).The posterior part of the mitral annulus AN is not reinforced by otherstructures of the heart and is rather discontinuous (making it prone todilatation). The leaflets AL, PL and the annulus AN are comprised ofdifferent types of cardiac tissue having varying strength, toughness,fibrosity, and flexibility. Furthermore, the mitral valve MV may alsocomprise a region of tissue interconnecting each leaflet to the annulusAN (indicated at dashed line in FIG. 2E).

A person of ordinary skill in the art will recognize that the dimensionsand physiology of the patient may vary among patients, and although somepatients may comprise differing physiology, the teachings as describedherein can be adapted for use by many patients having variousconditions, dimensions and shapes of the mitral valve. For example,research suggests that patients may have a long dimension across theannulus and a short dimension across the annulus with or withoutwell-defined peak and valley portions, and the methods and devices asdescribed herein can be configured accordingly.

Embodiments of devices and associated methods of use for treatingvalvular regurgitation by repairing and/or preventing at least oneleaflet of a native heart valve from prolapsing to reduce or eliminatevalvular regurgitation in accordance with embodiments hereof aredescribed with reference to FIGS. 3-17. As will be described in moredetail herein, the prolapse prevention devices described herein arepre-set or pre-shaped wires or wire-like structures that may bestraightened into an extremely low profile for percutaneoustranscatheter delivery and deployment into the atrial space. Whendeployed or expanded within an atrium of a heart to their pre-set orpre-shaped configuration, the prolapse prevention devices describedherein include a circumferential centering feature as well as alongitudinal positioning feature so that a leaflet backstop portionthereof is accurately positioned to limit or restrain motion of aprolapsing leaflet into the atrium of a heart. The prolapse preventiondevices described herein are self-adjustable and tunable to avoid orminimize abrasion of the atrium and/or native valve leaflets, and theminimal material thereof avoids obstructing other anatomic structuresbranching from the atrium such as the pulmonary veins. Further, as willbe explained in more detail herein, positioning of the prolapseprevention devices described herein may be evaluated before releasethereof from a delivery catheter and may be recaptured and re-deployedif adjustments to the positioning are desired. Further advantages of theprolapse prevention devices will be described in more detail herein withrespect to the figures. It will be appreciated that specific elements,substructures, uses, advantages, and/or other aspects of the embodimentsdescribed herein and with reference to FIGS. 3-17 can be suitablyinterchanged, substituted or otherwise configured with one another inaccordance with additional embodiments described herein.

Turning to FIG. 3, FIG. 3 is a perspective view of an implantableprosthesis or prolapse prevention device 300 for treating regurgitationof a heart valve due to a prolapsing leaflet. The prolapse preventiondevice 300 includes a delivery configuration, in which the prolapseprevention device 300 is substantially straightened for percutaneousdelivery within a delivery catheter to the treatment site (i.e., to theheart valve) as will be described in more detail herein with respect toFIG. 9, and a deployed configuration which is shown in FIG. 3. When theprolapse prevention device 300 is in the deployed configuration at thesite of a heart valve suffering from a prolapsing leaflet andregurgitation, the prolapse prevention device 300 is configured toprevent the leaflet from prolapsing, thereby reducing or eliminatingvalvular regurgitation as described below.

The prolapse prevention device 300 is an implantable prosthesis formedby a wire or wire-like structure 302 having a first end 304 and a secondend 306 that opposes the first end 304. The first end 304 and the secondend 306 are disconnected, detached, or otherwise separated from eachother. In an embodiment, as described in more detail herein, the firstend 304 and the second end 306 are formed in the shape of a hook topermit subsequent retrieval of the prolapse prevention device 300. Thewire-like structure 302 is a continuous strand or component that isformed from a self-expanding material and is pre-set in its deployedconfiguration shown in FIG. 3. Stated another way, in order to transformor self-expand between the delivery configuration and the deployedconfiguration, the prolapse prevention device 300 is formed from aresilient or shape memory material, such as a nickel titanium alloy(e.g., nitinol), that has a mechanical memory to return to the deployedor expanded configuration. Suitable resilient or shape memory materialsinclude stainless steel, a pseudo-elastic metal such as nickel titaniumalloy or nitinol, a so-called super alloy, which may have a base metalof nickel, cobalt, chromium, or other metal, MP35N spring wire, anacetal copolymer, or a polymeric material having shape memorycharacteristics. The material of the wire-like structure 302 has aninherent spring restorative force or mechanical memory to return to itsoriginal pre-set or preformed shape after being loaded. “Resilient” and“resilience” as used herein to refer to a material that is capable ofrecovering an original pre-set shape or form after being elasticallystretched, deformed, compressed, or the like. Mechanical memory may beimparted to the wire-like structure 302 that forms the prolapseprevention device 300 by thermal treatment to achieve a spring temper instainless steel, for example, or to set a shape memory in a susceptiblemetal alloy, such as nitinol. For example, the wire-like structure 302of the prolapse prevention device 300 may be shape-set into the closedconfiguration using an oven set to an appropriate temperature for thematerial, by e.g., approximately 525° C. for nitinol although thetemperature will vary depending on the material of the wire-likestructure 302.

In various embodiments in accordance herewith, the wire-like structure302 may be solid or hollow and have a circular cross-section. Byminimizing the cross-section of the wire-like structure 302, the amountof foreign material implanted in the body and the interruption orfootprint of the implant relative to blood flow is minimized to avoidthrombosis. In one embodiment, the wire-like structure 302 has adiameter less than 0.10 inches. In one embodiment, the wire-likestructure 302 has a diameter between 0.006 inches-0.040 inches. Inanother embodiment, the cross-section of the wire-like structure 302 maybe an oval, square, rectangular, or any other suitable shape, as well ascombinations thereof in which the cross-section of the wire-likestructure changes along the length thereof.

The wire-like structure 302 is shaped to include an inner tail 308, acentering ring 310, a leaflet backstop 312, a vertical support 314having an apex 316, and a retrieval arm 318. Although separatelydescribed, such portions or sections of the wire-like support 302 areintegrally formed such that the prolapse prevention device 300 is aunitary structure formed from a single piece of material. The portionsor sections of the wire-like support 302 are separately described suchthat the shape, structure, function and advantages thereof are clear.The portions or sections of the wire-like support 302 collectivelyenable or configure the prolapse prevention device 300 in the deployedconfiguration to prevent at least a first leaflet of the heart valvefrom prolapsing. More particularly, the prolapse prevention device 300in the deployed configuration causes a prolapsing first leaflet to coaptwith a second leaflet of the heart valve when the heart valve is in aclosed configuration and thereby prevents and/or repairs valvularregurgitation.

Each integral portion or section of the wire-like support 302 will nowbe described in more detail in turn with respect to FIG. 3. The leafletbackstop 312 of the prolapse prevention device 300 extends radiallyinward from the centering ring 310 and is configured to contact at leasta first leaflet of a native heart valve in situ. Along the length of thewire-like structure 302, the leaflet backstop 312 integrally extendsbetween the inner tail 308 and the centering ring 310. Moreparticularly, when positioned in situ, the leaflet backstop 312 extendsradially inward from the centering ring 310 towards a free or unattachededge of a prolapsing native leaflet. The prolapse prevention device 300is shaped to position or dispose the leaflet backstop 312 directly above(i.e., in an upstream direction) the prolapsing native leaflet in situsuch that at least the prolapsing native leaflet is limited, restrained,or otherwise prevented from prolapsing into the atrium. Althoughembodiments herein describe that the leaflet backstop 312 is configuredto contact at least a first leaflet of a native heart valve, or at leasta prolapsing leaflet of a native heart valve, the leaflet backstop 312may be sized and configured to further contact a second ornon-prolapsing leaflet of the native heart valve.

As best shown in the side view of FIG. 4, in an embodiment hereof, theleaflet backstop 312 extends at a downward (i.e., in a downstreamdirection) angle from the centering ring 310 to ensure downward pressureis exerted onto at least the prolapsing native leaflet. Stated anotherway, the centering ring 310 lies within or along a first plane P₁ andthe leaflet backstop 312 lies within or along a second plane P₂ when theprolapse prevention device 300 is in the deployed configuration. Asshown in FIG. 4, an angle θ₁ is formed between the first plane P₁ andthe second plane P₂. In an embodiment, angle θ₁ is between fifteendegrees and sixty degrees, and in another embodiment, angle θ₁ isbetween zero and twenty degrees.

In the embodiment of FIG. 3, the leaflet backstop 312 has a cross or “t”shaped configuration. More particularly, the cross configuration ofleaflet backstop 312 includes a first stem or leg 313A, a second stem orleg 313B, a first lobe or arm 311A, and a second lobe or arm 311B. Thefirst leg 313A and the second leg 313B are aligned and parallel to eachother. In the embodiment of FIG. 3, the second leg 313B is longer thanthe first leg 313A. However, the second leg 313B may be shorter than thefirst leg 313A or may be the same length as the first leg 313A. Thefirst arm 311A and the second arm 311B are aligned and parallel to eachother. In the embodiment of FIG. 3, the first arm 311A and the secondarm 311B are the same length. However, the first arm 311A and the secondarm 311B may be different lengths. The first leg 313A and the second leg313B extend perpendicular to the first arm 311A and the second arm 311Bin order to form the cross configuration of the leaflet backstop 312.The cross configuration covers a wide or large amount of surface area,thus ensuring sufficient downward pressure is exerted onto a nativevalve leaflet by the leaflet backstop 312 and making it easier tocorrectly position the prolapse prevention device 300. Although thecross or “t” shaped configuration of the leaflet backstop 312illustrated in FIG. 3 includes only a single pair of lobes or arms(i.e., the first arm 311A and the second arm 311B) extending radiallyoutwardly from the first leg 313A and the second leg 313B, in anotherembodiment hereof (not shown) the leaflet backstop may include two ormore pairs of lobes or arms extending radially outwardly from the firstleg 313A and the second leg 313B.

The centering ring 310 is a circumferential centering feature of theprolapse prevention device 300. More particularly, the centering ring310 is configured to seat just above, or adjacent to and upstream of, anannulus of a heart valve to circumferentially center the prolapseprevention device 300 with respect to the annulus of the heart valve insitu. As used herein, “adjacent to and upstream of” or “just above” anannulus of a heart valve means that the centering ring is disposeddirectly above a plane of the annulus of the native valve, includingdisposition at or on a level of an upper surface of the annulus or othersuperior levels of the valve. The centering ring 310 exerts radialpressure onto the surrounding native tissue to anchor the prolapseprevention device 300 in place. While the centering ring 310 of FIG. 3is shown with a specific shape, i.e., circular, this is by way ofexample and not limitation, and it will be understood that the centeringring 310 may assume any number of alternative shapes suitable to treatvalvular regurgitation. The shape of the centering ring 310 may beselected based upon the shape of the native anatomy and/or desiredanchoring positions. While shown as circular, the centering ring 310 mayhave other shapes including but not limited to an ellipse, an oval,D-shaped, or any other shape suitable for the purposes described herein.Further, the resilient nature of the wire-like structure 302 permits thecentering ring 310 to conform to the shape of the surrounding nativetissue in situ. Along the length of the wire-like structure 302, thecentering ring 310 integrally extends between the leaflet backstop 312and the vertical support 314.

The inner tail 308 abuts or conforms to an inner surface of thecentering ring 310 and permits the centering ring 310 to self-adjust insize to the surrounding native tissue in situ. More particularly, thecentering ring 310 is an open ring having a first end 315A and a secondend 315B. “Open ring” as used herein means that the centering ring 310is an annular component in which the first end 315A is not attached tothe second end 315B. The open ring structure of the centering ring 310in combination with the inner tail 308 allows for natural anatomicalsizing of the centering ring 310 so that the centering ring 310 mayconform to a range of sizes of native anatomies and anchor the prolapseprevention device 300 therein. More particularly, the centering ring 310of the prolapse prevention device 300 is shown in FIG. 3 with only arelatively small space or gap 319 extending between the first end 315Aand the second end 315B thereof If the prolapse prevention device 300 isdeployed within an anatomy requiring the centering ring 310 to have agreater diameter than shown in FIG. 3, the centering ring 310 radiallyexpands such that the diameter thereof increases and the gap 319 widensas the first end 315A of the centering ring 310 moves apart from thesecond end 315B of the centering ring 310. Further, as the centeringring 310 radially expands, the amount of overlap between the centeringring 310 and the inner tail 308 decreases. When the amount of overlapbetween the centering ring 310 and the inner tail 308 decreases, atleast a portion of the inner tail 308 is uncovered (i.e., is no longercovered by or disposed within the centering ring 310) and thus serves toexert radial pressure onto the surrounding native tissue to anchor theprolapse prevention device 300 in place. Stated another way, the innertail 308 is a back-up or standby structure that serves tocircumferentially center and anchor the prolapse prevention device 300into place as the centering ring 310 radially expands. Conversely, ifthe prolapse prevention device 300 is deployed within an anatomyrequiring the centering ring 310 to have a smaller diameter, thecentering ring 310 radially contracts such that the diameter thereofdecreases and the gap 319 shortens as the first end 315A of thecentering ring 310 moves closer to the second end 315B of the centeringring 310. In some embodiments, the gap 319 may disappear such that thefirst end 315A and the second end 315B of the centering ring 310 abutagainst each other and/or overlap. Since the inner tail 308 is notattached to the inner surface of the centering ring 310, the inner tail308 and the centering ring 310 essentially slide or move relative toeach other to permit expansion or contraction of the centering ring 310,thereby decreasing or increasing the amount of overlap between thecentering ring 310 and the inner tail. Along the length of the wire-likestructure 302, the inner tail 308 integrally extends between the firstend 304 of the wire-like structure 302 and the leaflet backstop 312. Thefirst end 304 of the wire-like structure 302 and the inner tail 308 liewithin or along the same plane as the centering ring 310, namely thefirst plane Pi shown on the side view of FIG. 4, when the prolapseprevention device 300 is in the deployed configuration.

The vertical support 314 is a longitudinal positioning feature of theprolapse prevention device 300. More particularly, the vertical support314 extends in an upward or upstream direction from the centering ring310 such that the apex 316 thereof is configured to seat against a roofof the atrium in situ. The vertical support 314 is a longitudinalpositioning feature because it braces the wire-like structure 302against the roof of the atrial wall, thereby seating the leafletbackstop 312 just above, or adjacent to and upstream of, the annulus ofa heart valve. Stated another way, the vertical support 314 isconfigured to longitudinally position the prolapse prevention device 300within an atrium of the heart such that the leaflet backstop 312contacts a prolapsing first leaflet of the heart valve when the prolapseprevention device 300 is deployed within the atrium. Collectively, thecentering ring 310 and/or the vertical support 314 eliminate or minimizecanting of the prolapse prevention device 300, or stated another way,position prolapse prevention device 300 in situ such that the plane P₁(see FIG. 4) of the centering ring 310 is substantially parallel to aplane of the annulus of the native mitral valve MV. Along the length ofthe wire-like structure 302, the vertical support 314 integrally extendsbetween the centering ring 310 and the retrieval arm 318.

As best shown in the side view of FIG. 4, in an embodiment hereof, thevertical support 314 extends at an angle from the centering ring 310 tominimize obstruction or interference with other anatomic features withinthe atrium such as the pulmonary veins. Stated another way, thecentering ring 310 lies within or along the first plane Pi and thevertical support 314 lies within or along a third plane P₃ when theprolapse prevention device 300 is in the deployed configuration. Asshown in FIG. 4, an angle θ₂ is formed between the first plane P₁ andthe third plane P₃. In an embodiment, angle θ₂ is between forty-fivedegrees and eighty degrees, and in another embodiment, angle θ₂ isbetween eighty degrees and one hundred degrees.

The last integral portion or section of the wire-like structure 302 tobe described is the retrieval arm 318. Along the length of the wire-likestructure 302, the retrieval arm 318 integrally extends between thevertical support 314 and the second end 306 of the wire-like structure302. The retrieval arm 318 is the last integral portion or section ofthe wire-like structure 302 to be deployed in situ, and primarilyfunctions to permit retrieval of the prolapse prevention device 300after full deployment of the prolapse prevention device 300. Suchretrieval of the prolapse prevention device 300 is discussed in moredetail below with respect to the method steps illustrated in FIGS.10-15. The retrieval arm 318 extends in a downward or downstreamdirection from the apex 316 of the vertical support 314. As shown inFIG. 3, the retrieval arm 318 may be curved or rounded so as to beatraumatic within the atrium.

As described above, the wire-like structure 302 preferably integrallyincludes the inner tail 308, the centering ring 310, the leafletbackstop 312, the vertical support 314, and the retrieval arm 318 suchthat the prolapse prevention device 300 is a unitary structure formedfrom a single piece of material. However, in another embodiment, one ormore of the above-described sections or portions of the prolapseprevention device 300 may be formed as a separate component that issubsequently attached to the remaining sections or portions to form thecontinuous wire-like structure 302 by any suitable manner known in theart such as for example welding, including resistance welding, frictionwelding, laser welding or another form of welding, soldering, using anadhesive, adding a connecting element there between, or by anothermechanical method. For example, in an embodiment hereof, it may bedesirable to form the retrieval arm 318 of a radiopaque material to aidin retrieval of the prolapse prevention device 300. The retrieval arm318 may be formed as a separate component and subsequently attached tothe vertical support 314 to form the continuous wire-like structure 302.In another embodiment, the retrieval arm 308 may be formed integrallywith the remainder of the wire-like structure 302 and coated withradiopaque material.

As described above, in the embodiment of FIG. 3, the leaflet backstop312 has a cross or “t” shaped configuration but the leaflet backstop mayhave other configurations configured to contact at least a first leafletof a native heart valve in situ. More particularly, FIG. 5 is aperspective illustration of a prolapse prevention device 500 fortreating heart valvular regurgitation in accordance with anotherembodiment hereof, wherein a leaflet backstop 512 of the prolapseprevention device 500 has a wavy configuration. Similar to the prolapseprevention device 300, the prolapse prevention device 500 is formed froma wire-like structure 502 having a first end 504 and a second end 506that opposes the first end 504. The first end 504 and the second end 506are disconnected, detached, or otherwise separated from each other. Thewire-like structure 502 is a continuous strand or component that isformed from a self-expanding material and is pre-set in its deployedconfiguration shown in FIG. 5. The wire-like structure 502 is shaped toinclude an inner tail 508 (which is similar in structure and function tothe inner tail 308), a centering ring 510 (which is similar in structureand function to the centering ring 310), the leaflet backstop 512, avertical support 514 having an apex 516 (which is similar in structureand function to the vertical support 314), and a retrieval arm 518(which is similar in structure and function to the retrieval arm 318).The leaflet backstop 512 extends radially inward from the centering ring510 and has a wavy or sinusoidal configuration as shown in FIG. 5.Similar to the leaflet backstop 312, the leaflet backstop 512 preferablyextends at a downward or downstream angle from the centering ring 510 toensure downward pressure on the prolapsing native leaflet.

FIG. 6 is a perspective illustration of a prolapse prevention device 600for treating heart valvular regurgitation in accordance with anotherembodiment hereof, wherein a leaflet backstop 612 of the prolapseprevention device 600 has a circular or partial ring configuration.Similar to the prolapse prevention device 300, the prolapse preventiondevice 600 is formed from a wire-like structure 602 having a first end604 and a second end 606 that opposes the first end 604. The first end604 and the second end 606 are disconnected, detached, or otherwiseseparated from each other. The wire-like structure 602 is a continuousstrand or component that is formed from a self-expanding material and ispre-set in its deployed configuration shown in FIG. 6. The wire-likestructure 602 is shaped to include an inner tail 608 (which is similarin structure and function to the inner tail 308), a centering ring 610(which is similar in structure and function to the centering ring 310),the leaflet backstop 612, a vertical support 614 having an apex 616(which is similar in structure and function to the vertical support314), and a retrieval arm 618 (which is similar in structure andfunction to the retrieval arm 318). The leaflet backstop 612 extendsradially inward from the centering ring 610 and has a partial ringconfiguration as shown in FIG. 6. Similar to the leaflet backstop 312,the leaflet backstop 612 preferably extends at a downward or downstreamangle from the centering ring 610 to ensure downward pressure on theprolapsing native leaflet.

In addition, the vertical support may have other configurations beyondthe configuration shown in FIG. 3. More particularly, FIG. 7 is aperspective illustration of a prolapse prevention device 700 fortreating heart valvular regurgitation in accordance with anotherembodiment hereof, wherein an apex 716 of a vertical support 714 of theprolapse prevention device 700 includes a sinusoidal portion 717.Similar to the prolapse prevention device 300, the prolapse preventiondevice 700 is formed from a wire-like structure 702 having a first end704 and a second end 706 that opposes the first end 704. The first end704 and the second end 706 are disconnected, detached, or otherwiseseparated from each other. The wire-like structure 702 is a continuousstrand or component that is formed from a self-expanding material and ispre-set in its deployed configuration shown in FIG. 7. The wire-likestructure 702 is shaped to include an inner tail 708 (which is similarin structure and function to the inner tail 308), a centering ring 710(which is similar in structure and function to the centering ring 310),the leaflet backstop 712 (which is similar in structure and function tothe leaflet backstop 312), the vertical support 714 having the apex 716,and a retrieval arm 718 (which is similar in structure and function tothe retrieval arm 318). The apex 716 of the vertical support 714 has thewavy or sinusoidal portion 717 as shown in FIG. 7. Compared to the apex316 of the vertical support 314, the apex 716 having the sinusoidalportion 717 has an increased surface area and thus contacts a relativelygreater amount of the roof of the atrium for improved bracing of theprolapse prevention device 700. Stated another way, the orientation ofthe sinusoidal portion 717 is along the roof of the atrium (such thatthe sinusoidal portion 717 is abutting against and contacting the roofof the atrium) rather than extending up and down within the atrium.Similar to the vertical support 314, the vertical support 714 preferablyextends at an upward or upstream angle from the centering ring 710 tominimize obstruction or interference with other anatomic features withinthe atrium such as the pulmonary veins.

In another embodiment hereof, the vertical support may be configured toabut against or conform to at least a portion of a sidewall of theatrium along a length thereof. More particularly, FIG. 8 is aperspective illustration of a prolapse prevention device 800 fortreating heart valvular regurgitation in accordance with anotherembodiment hereof, wherein the vertical support 814 of the prolapseprevention device 800 is curved to be configured to hug or abut againsta sidewall of the left atrium of the heart in situ. Similar to theprolapse prevention device 300, the prolapse prevention device 800 isformed from a wire-like structure 802 having a first end 804 and asecond end 806 that opposes the first end 804. The first end 804 and thesecond end 806 are disconnected, detached, or otherwise separated fromeach other. The wire-like structure 802 is a continuous strand orcomponent that is formed from a self-expanding material and is pre-setin its deployed configuration shown in FIG. 8. The wire-like structure802 is shaped to include an inner tail 808 (which is similar instructure and function to the inner tail 308), a centering ring 810(which is similar in structure and function to the centering ring 310),the leaflet backstop 812 (which is similar in structure and function tothe leaflet backstop 312), the curved vertical support 814 as describedabove and having an apex 816, and a retrieval arm 818 (which is similarin structure and function to the retrieval arm 318).

Although embodiments hereof are depicted with a single vertical support,in other embodiments hereof, the prolapse prevention devices describedabove may include multiple vertical supports, each of which includes anapex configured to seat against a roof of the atrium in situ. Comparedto embodiments having a single vertical support, two or more verticalsupports may provide improved bracing of the prolapse prevention device.

Turning now to FIG. 9, FIG. 9 is a side view illustration of a deliverycatheter 920 for delivering a prolapse prevention device according to anembodiment hereof. For exemplary purposes only, FIG. 9 illustrates theprolapse prevention device 300 in a delivery configuration disposedwithin the delivery catheter 920 but FIG. 9 can similarly be utilized todeliver any embodiment of the prolapse prevention devices describedherein. In addition, the delivery catheter 920 is merely exemplary andother suitable delivery devices may be utilized to deliver the prolapseprevention device 300.

Delivery catheter 920 is an elongated device including an outer shaft orsheath 924 configured for delivery through the vasculature, an innermember 930 disposed within the outer sheath 924, and a claspingmechanism 936 disposed at a distal end 934 of the inner member 930 ofthe delivery catheter 920. More particularly, the outer sheath 924includes a proximal end 926 which is coupled to a handle 922 at aproximal end of the delivery catheter 920 and a distal end 928 which ispositionable at a treatment site in situ. The inner member 930, which isdisposed within the outer sheath 924 and moveable relative thereto,includes a proximal end 932 which is also coupled to the handle 922 andthe distal end 924. The clasping mechanism 936 is configured to graspand hold the second end 306 of the wire-like structure 302 of theprolapse prevention device 300, as shown in FIG. 9. The wire-likestructure 302 of the prolapse prevention device 300 is held in thedelivery configuration via the outer sheath 924, which surrounds andsubstantially straightens the prolapse prevention device 300 to easeadvancement thereof through the vasculature to the treatment site withina body vessel. “Substantially straightened” or “substantially straight”as used herein includes wire-like structures that extend parallel to alongitudinal axis L_(A) of the delivery catheter 920 within a toleranceof 15 degrees. Due to the substantially straight or linear deliveryconfiguration of the prolapse prevention device 300, the deliverycatheter 920 has a low profile of less than 7 French. In an embodimenthereof, the delivery catheter has a very low profile of 4 French. Thevery low profile of the prolapse prevention device 300 increases accessroute options for delivery into the left atrium of a heart, includingfemoral or radial transseptal access routes as described in more detailherein with respect to FIG. 10. In the substantially straight deliveryconfiguration, the entire length of the prolapse prevention device 300is disposed within the outer sheath 924. In an embodiment, when in thesubstantially straight delivery configuration, the length of theprolapse prevention device 300 is between 6-20 inches. In an embodiment,when in the substantially straight delivery configuration, the length ofthe prolapse prevention device 300 is approximately three times aperimeter of an annulus of a mitral heart valve.

The outer sheath 924 is movable in a longitudinal direction along andrelative to the inner member 930 and is user controlled via an actuator(not shown) on the handle 922. When the actuator is operated, the outersheath 924 is either proximally retracted or distally advanced relativeto the inner member 930. Thus, once the prolapse prevention device 300is properly positioned and it is desired to deploy the prolapseprevention device 300, the outer sheath 924 and the inner member 930 maybe moved relative to each other such that the prolapse prevention device300 is released from the outer sheath 924 and allowed to assume itspre-set or pre-shaped deployed configuration shown in FIG. 3. To causethe relative motion between the outer sheath 924 and the inner member930, the inner member 930 (as well as the clasping mechanism 936 and theprolapse prevention device 300 held therein) may be distally advancedwhile the outer sheath 924 is held in place so that the prolapseprevention device 300 is essentially pushed out of the distal end 928 ofthe outer sheath 924, or the outer sheath 924 may be retracted in aproximal direction while the inner member 930 (as well as the claspingmechanism 936 and the prolapse prevention device 300 held therein) isheld in place so that the prolapse prevention device 300 is essentiallyexposed, or a combination thereof. As the prolapse prevention device 300exits the outer sheath 924, each integral portion or section of theprolapse prevention device 300 assumes its pre-set or pre-shapeddeployed configuration due to the inherent spring restorative force ofthe wire-like structure 302 of the prolapse prevention device 300.

The clasping mechanism 936 is shown including a pair of jaws 938A, 938B.However, any clasping or snare mechanism suitable to grasp and hold thesecond end 306 of the wire-like structure 302 may be utilized. In oneembodiment, the jaws 938A, 938B are displaceable towards and away fromone another and are formed from a resilient material. In an embodiment,the jaws 938A, 938B are biased into a normally open configuration.During delivery to the treatment site or location, the outer sheath 924extends over the clasping mechanism 936 to maintain the jaws 938A, 938Bin a closed configuration as well as to maintain the wire-like structure302 in a substantially straight delivery configuration as describedabove. When it is desired to open the jaws 938A, 938B and therebyrelease the prolapse prevention device 300, the outer sheath 924 isfurther retracted proximally to expose the jaws 938A, 938B such thattheir natural bias opens the jaws 938A, 938B and thereby releases thesecond end 306 of the wire-like structure 302. Other clasping mechanismsmay be utilized. For example, and not by way of limitation, the jaws maybe opening and closed by a mechanical linkage extending proximally to ahandle which is operated by the user. Other clasping mechanisms which donot necessarily include two jaws, may also be utilized such as a snaringhook or snaring lasso.

FIGS. 10-15 are sectional cut-away views of a heart HE illustratingmethod steps of treating regurgitation at a mitral valve MV via atransseptal approach for delivering and deploying the prolapseprevention device 300 of FIG. 3 in accordance with an embodiment hereof.Access to the mitral valve MV can be accomplished through a patient'svasculature in a percutaneous manner. In an embodiment, the approach tothe mitral valve is antegrade and may be accomplished via entry into theleft atrium by crossing the interatrial septum. As is known in the art,a guidewire (not shown) may be advanced intravascularly using any numberof techniques, e.g., through the inferior vena cava or superior venacava (FIG. 1), into the right atrium RA through a penetration hole cutin the inter-atrial septum (not shown) and into the left atrium LA (FIG.1). A guide catheter (not shown) may be advanced along the guidewire andinto the right atrium RA, through the penetration hole in theinter-atrial septum, and into the left atrium LA. The guide catheter mayhave a pre-shaped or steerable distal end to shape or steer the guidecatheter such that it will direct the delivery catheter 920 toward themitral valve MV.

Alternatively, the mitral valve may also be accessed via a transatrialapproach for e.g., directly through an incision in the left atrium LA.Access to the heart may be obtained through an intercostal incision inthe chest without removing ribs, and a guiding catheter (not shown) maybe placed into the left atrium LA through an atrial incision sealed witha purse-string suture. The delivery catheter 920 may then be advancedthrough the guiding catheter to the mitral valve. Alternatively, thedelivery catheter 920 may be modified to include a guidewire lumen suchthat it may be tracked over a guidewire and placed directly through theatrial incision without the use of a guiding catheter.

Referring to FIG. 10, the distal end 928 of the outer sheath 924 of thedelivery catheter 920 is shown positioned in the left atrium LA. Thedelivery catheter 920 is delivered through the vasculature into the leftatrium LA with the prolapse prevention device 300 in the deliveryconfiguration. Intravascular access to the right atrium RA may beachieved via a percutaneous access site in a femoral, brachial, radial,or axillary artery. As will be understood by those knowledgeable in theart, the handle 922 as well as some length of a proximal segment of thedelivery catheter 920, are exposed externally of the patient for accessby a clinician. By manipulating the handle 922 of the delivery catheter920 from outside the vasculature, a clinician may advance and remotelymanipulate and steer the distal end 928 of the outer sheath 924 of thedelivery catheter 920 through the sometimes tortuous intravascular path.

With reference to FIG. 11, the delivery catheter 920 is distallyadvanced until the distal end 928 of the outer sheath 924 of thedelivery catheter 920 is positioned just above (e.g., adjacent to andupstream of) the mitral valve MV to deliver the prolapse preventiondevice 300 to the mitral valve MV. Advantageously there is no need tocross the mitral valve MV during deployment of the prolapse preventiondevice 300, which poses a risk of damaging the native valve leaflets.

Once the delivery catheter 920 is properly positioned for deployment ofthe prolapse prevention device 300 as described above, the outer sheath924 is proximally retracted as shown in FIG. 12 to at least partiallydeploy the prolapse prevention device 300. Upon retraction of the outersheath 924, each integral portion or section of the prolapse preventiondevice 300 assumes its pre-set or pre-shaped deployed configuration dueto the inherent spring restorative force of the wire-like structure 302of the prolapse prevention device 300. In FIG. 12, the first end 304,the inner tail 308, the centering ring 310, and the leaflet backstop 312are shown deployed while the remaining integral portions of the prolapseprevention device 300 (i.e., the vertical support 314 and the retrievalarm 318) are still disposed within the outer sheath 924.

After partial deployment of the prolapse prevention device 300, aphysician may evaluate the positioning of the prolapse prevention device300 prior to full deployment thereof. “Partial deployment” as usedherein includes deployment of at least one integral portion or sectionof the prolapse prevention device 300. “Partial deployment” as usedherein further includes deployment of all integral portions or sectionsof the prolapse prevention device 300 as long as the second end 306 ofthe wire-like structure 302 is still held or retained within theclasping mechanism 936 of the delivery catheter 920. Thus, the physicianmay deploy, for example, approximately 80-95% of the prolapse preventiondevice 300 and then evaluate the position and suitability of theprolapse prevention device 300 before full deployment thereof. “Fulldeployment” as used herein includes deployment of all integral portionsor sections of the prolapse prevention device 300 as well as the secondend 306 of the wire-like structure 302 such that the prolapse preventiondevice 300 is no longer coupled to a delivery device. If the leafletbackdrop 312 is not exerting sufficient downward pressure to repair theprolapsing native leaflet as desired, the physician can recapture theprolapse prevention device 300 such that the prolapse prevention device300 can be repositioned and re-deployed.

More particularly, if a physician desires to recapture the prolapseprevention device 300 after partial deployment hereof, the outer sheath924 is distally advanced to cover and re-constrain the wire-likestructure 302. As the outer sheath 924 is advanced over the wire-likestructure 302, the wire-like structure 302 resumes its substantiallystraight delivery configuration. The delivery catheter 920 may berepositioned if desired, and the outer sheath 924 is then proximallyretracted to at least partially re-deploy the prolapse prevention device300 as described above with respect to FIG. 12. The steps of recapturingthe prolapse prevention device 300 and at least partially re-deployingthe prolapse prevention device 300 may be repeated until the desiredpositioning of the prolapse prevention device 300 within the left atriumis achieved.

Image guidance, enhanced echogenicity, or other methods may be used toaid the clinician's delivery and positioning of the prolapse preventiondevice 300. Image guidance, e.g., intracardiac echocardiography (ICE),fluoroscopy, computed tomography (CT), intravascular ultrasound (IVUS),optical coherence tomography (OCT), or another suitable guidancemodality, or combination thereof, may be used to aid the clinician'spositioning and manipulation of the prolapse prevention device 300 atthe target native valve region. For example, such image guidancetechnologies can be used to aid in determining how much of the prolapseprevention device 300 has been deployed. In some embodiments, imageguidance components (e.g., IVUS, OCT) can be coupled to the distalportion of the delivery catheter 920, the guide catheter, or both toprovide three-dimensional images of the area proximate to the targetheart valve region to facilitate positioning, orienting and/ordeployment of the prolapse prevention device 300 within the heart valveregion.

With reference to FIG. 13, after the partial deployment and desiredpositioning of the prolapse prevention device 300 within the left atriumis achieved, the prolapse prevention device 300 is fully deployed byretracting the outer sheath 924 until the second end 306 of thewire-like structure 302 is released by the clasping mechanism 936 andthe prolapse prevention device 300 is no longer coupled to the deliverycatheter 920. As shown in FIG. 13, the outer sheath 924 is proximallyretracted to permit the jaws 938A, 938B to open and thereby release thesecond end 306 of the wire-like structure 302. In the deployedconfiguration, the centering ring 310 of the prolapse prevention device300 is seated just above, or adjacent to and upstream of, the annulus ofthe mitral valve MV, the vertical support 314 of the prolapse preventiondevice 300 extends from the centering ring 310 and the apex 316 thereofis seated against a roof of the left atrium, and the leaflet backstop312 of the prolapse prevention device 300 extends radially inward fromthe centering ring 310 and contacts at least the posterior leaflet PL ofthe mitral valve MV to prevent the posterior leaflet PL from prolapsinginto the left atrium. The centering ring 310 and/or the vertical support314 serve to eliminate or minimize canting of the prolapse preventiondevice 300, or stated another way, serve to position prolapse preventiondevice 300 in situ such that after implantation thereof the plane P₁(see FIG. 4) of the centering ring 310 is substantially parallel to aplane of the annulus of the native mitral valve MV.

If desired, the mitral valve MV may be checked for regurgitation afterfull deployment of the prolapse prevention device 300. Checking forregurgitation of the mitral valve MV may be accomplished by variousmethods including, but not limited to echocardiogram, to visualizeplacement of the leaflet backstop 312 and prolapse of the posteriorleaflet PL of the mitral valve MV. Accordingly, an echogenic coating maybe applied to one or more integral portions of the prolapse preventiondevice 300 to aid in visualization.

Following full deployment of the prolapse prevention device 300 at themitral valve MV, the delivery catheter 920 and remaining guidewires (ifany) may be removed from the heart H and out of the body of the patientas shown in FIGS. 14 and 15. Notably, the prolapse prevention device 300remains deployed within the left atrium without any secondary orinvasive anchoring components. More particularly, sutures, tines, barbs,or similar anchoring components are not required since the prolapseprevention device 300 as deployed braces itself within the atrium. Inaddition, the prolapse prevention device 300 as deployed exerts adownward (e.g., downstream) pressure on at least the posterior leafletand thus there is no need for leaflet capture, which poses a risk ofdamaging the native valve leaflets. Lastly, the prolapse preventiondevice 300 as deployed does not reduce or alter the cross-sectional areaof the mitral valve MV and thus reduced blood flow through the mitralvalve MV is avoided and easy access to the mitral valve MV is stillpermitted for future therapies and treatments.

While FIGS. 10-15 illustrate the delivery and deployment of the prolapseprevention device 300 at the mitral valve MV, it will be understood thatthe method steps may be used to deliver and deploy any embodiment ofprolapse prevention devices described herein.

The prolapse prevention device 300 is also retrievable after fulldeployment thereof. More particularly, in the event that the prolapseprevention device 300 needs to be repositioned, removed and/or replacedafter implantation, the wire-like structure 302 can transition from thedeployed configuration back to the substantially straightened deliveryconfiguration using delivery catheter 920 or a similar snare-typedevice. The prolapse prevention device 300 is retrievable for a certaintime period after full deployment thereof, i.e., is retrievable untilthe prolapse prevention device 300 has endothelialized. Stated anotherway, the prolapse prevention device 300 may be removed or repositioneduntil the prolapse prevention device 300 has endothelialized. Forexample, it may be desirable to reposition the prolapse preventiondevice 300 to account for changes in the native anatomy over time.

Notably, the first end 304 and the second end 306 of the wire-likestructure 302 are each configured to permit easy retrieval thereof viathe delivery catheter 920 or a similar snare-type device because thefirst end 304 and the second end 306 of the wire-like structure 302 areeach formed in the shape of a hook with an integral bend or curve. Inaddition, in an embodiment, the wire-like structure 302 is radiopaque.In another embodiment, at least the second end 306 of the wire-likestructure 302 includes a radiopaque coating. The term “radiopaque”refers to the ability of a substance to absorb X-rays. The radiopaquematerial or coating allows at least the second end 306 of the wire-likestructure 302 to be visible under X-ray or fluoroscopic imagingequipment. Few substances will transmit 100% of X-rays and fewsubstances will absorb 100% of X-rays. For the purposes of thisdisclosure, radiopaque will refer to those substances or materials whichhave suitable visibility for retrieval procedures when being imaged byan X-ray imaging device such as but not limited to a fluoroscope.

If a physician desires to retrieve the prolapse prevention device 300after full deployment and/or implantation thereof, the delivery catheter920 or a similar snare-type device is delivered into the left atrium.The retrieval process will be described using the delivery catheter 920although other devices may be utilized. In addition, the retrievalprocess will be described using the second end 306 of the wire-likestructure 302 although the first end 304 may alternatively be utilized.The outer sheath 924 is proximally retracted to expose the jaws 938A,938B and permit expansion thereof. The opened jaws 928A, 938B are thenpositioned over the second end 306 of the wire-like structure 302. Theouter sheath 924 is then distally advanced to cover and re-constrain thejaws 938A, 938B, thereby closing the jaws 938A, 938B around the secondend 306 of the wire-like structure 302. With the second end 306 heldwithin the jaws 938A, 938B, the outer sheath 924 and/or the inner member930 are moved relative to each other in order to effectively positionthe wire-like structure 302 within the outer sheath 924 such that thewire-like structure 302 resumes its substantially straightened deliveryconfiguration. After retrieval thereof, the prolapse prevention device300 may be repositioned and redeployed or may be removed from thepatient.

Another advantage of the prolapse prevention device 300 is that itenables subsequent valve replacement after implantation thereof. Moreparticularly, a valve prosthesis may be deployed within the implantedprolapse prevention device 300. The implanted prolapse prevention device300 serves as a visualization aid for deployment of the valve prosthesisand/or a docking station for the valve prosthesis. For example, as shownin FIG. 16, a valve prosthesis 1650 is shown deployed within the leafletbackstop 312 of the deployed or implanted prolapse prevention device300. The valve prosthesis 1650 in a compressed configuration (not shown)is percutaneously introduced into a vasculature via a valve deliverydevice (not shown) and delivered to the implanted prolapse preventiondevice 300. The valve prosthesis 1650 in the compressed configuration ispositioned within the deployed or implanted prolapse prevention device300, and then the valve prosthesis 1650 is radially expanded or deployedwithin the leaflet backstop 312 of the deployed or implanted prolapseprevention device 300 as shown in FIG. 16. The leaflet backstop 312radially expands to accommodate the deployed valve prosthesis 1650, andthe deployed valve prosthesis 1650 is held or secured therein.

In another embodiment hereof, a valve prosthesis may be deployed withina centering ring of a deployed or implanted prolapse prevention device.For example, as shown in FIG. 17, a valve prosthesis 1750 is showndeployed within a leaflet backstop 1712 of a deployed or implantedprolapse prevention device 1700. Similar to the prolapse preventiondevice 300, the prolapse prevention device 1700 is formed from awire-like structure 1702 having a first end 1704 and a second end 1706that opposes the first end 1704. The first end 1704 and the second end1706 are disconnected, detached, or otherwise separated from each other.The wire-like structure 1702 is a continuous strand or component that isformed from a self-expanding material and is pre-set in its deployedconfiguration shown in FIG. 17. The wire-like structure 1702 is shapedto include an inner tail 1708 (which is similar in structure andfunction to the inner tail 308), a centering ring 1710 (which is similarin structure and function to the centering ring 310), the leafletbackstop 1712 (which is similar in structure and function to the leafletbackstop 312), the vertical support 1714 having the apex 1716 (which issimilar in structure and function to the vertical support 314), and aretrieval arm 1718 (which is similar in structure and function to theretrieval arm 318). The leaflet backstop 1712 is similar to the leafletbackstop 312 except that the leaflet backstop 1712 is also configured tobend or pivot in a downward (e.g., downstream) direction when the valveprosthesis 1750 is positioned or advanced through the deployed orimplanted prolapse prevention device 1700. The valve prosthesis 1750 isradially expanded or deployed within centering ring 1710 of the deployedor implanted prolapse prevention device 1700 as shown in FIG. 17. Thedeployed valve prosthesis 1750 is held or secured within the centeringring 1710 of the deployed or implanted prolapse prevention device 1700,and the leaflet backstop 1712 is displaced so as not to interfere withfunctioning of the valve prosthesis 1750.

Various method steps described above for delivery and deployment ofembodiments of the prolapse prevention devices within a native heartvalve of a patient may be interchanged to form additional embodiments ofthe present technology. For example, while the method steps describedabove are presented in a given order, alternative embodiments mayperform steps in a different order. The various embodiments describedherein may also be combined to provide further embodiments.

While various embodiments have been described above, it should beunderstood that they have been presented only as illustrations andexamples of the present technology, and not by way of limitation. Itwill be apparent to persons skilled in the relevant art that variouschanges in form and detail may be made therein without departing fromthe spirit and scope of the present technology. Thus, the breadth andscope of the present technology should not be limited by any of theabove-described embodiments but should be defined only in accordancewith the appended claims and their equivalents. It will also beunderstood that each feature of each embodiment discussed herein, and ofeach reference cited herein, may be used in combination with thefeatures of any other embodiment. All patents and publications discussedherein are incorporated by reference herein in their entirety.

What is claimed is:
 1. A prolapse prevention device for treatingvalvular regurgitation in a heart valve, the prolapse prevention devicecomprising: a continuous wire-like structure having a first end and asecond end that opposes the first end, the first end and the second endbeing disconnected from each other, wherein the continuous wire-likestructure of the prolapse prevention device is substantially straight ina delivery configuration, and wherein the continuous wire-like structureof the prolapse prevention device in a deployed configuration includes acentering ring configured to seat adjacent to and upstream of an annulusof the heart valve to circumferentially center the prolapse preventiondevice in situ, a vertical support extending from the centering ringsuch that an apex thereof is configured to seat against a roof of anatrium in situ, and a leaflet backstop extending radially inward fromthe centering ring and configured to contact at least a first leaflet ofthe heart valve in situ to exert a pressure in a downstream direction onthe first leaflet to prevent the first leaflet from prolapsing into theatrium.
 2. The prolapse prevention device of claim 1, wherein the heartvalve is a mitral heart valve and the first leaflet is a posteriorleaflet of the mitral heart valve.
 3. The prolapse prevention device ofclaim 1, wherein the prolapse prevention device is a unitary structureformed from a single piece of material.
 4. The prolapse preventiondevice of claim 1, wherein the continuous wire-like structure is formedfrom a self-expanding material and is pre-set in the deployedconfiguration.
 5. The prolapse prevention device of claim 1, wherein thecentering ring is an open ring and the continuous wire-like structurefurther includes an inner tail that conforms to an inner surface of thecentering ring.
 6. The prolapse prevention device of claim 5, whereinthe inner tail is configured to permit the open ring to self-adjust to asize of the annulus of the heart valve.
 7. The prolapse preventiondevice of claim 6, wherein the first end and the inner tail lie withinthe same plane as the centering ring when the prolapse prevention deviceis in the deployed configuration.
 8. The prolapse prevention device ofclaim 1, wherein the centering ring lies within a first plane and theleaflet backstop lies within a second plane when the prolapse preventiondevice is in the deployed configuration, the second plane being at anangle between fifteen degrees and seventy-five degrees from the firstplane and the second plane.
 9. The prolapse prevention device of claim1, wherein the leaflet backstop has a cross configuration.
 10. Theprolapse prevention device of claim 1, wherein the leaflet backstop hasa circular configuration.
 11. The prolapse prevention device of claim 1,wherein the leaflet backstop has a sinusoidal configuration.
 12. Theprolapse prevention device of claim 1, wherein the apex of the verticalsupport includes a sinusoidal portion.
 13. The prolapse preventiondevice of claim 1, wherein the vertical support is configured to abutagainst a sidewall of the atrium.
 14. A prolapse prevention device fortreating valvular regurgitation in a heart valve, the prolapseprevention device comprising: a continuous wire-like structure having afirst end and a second end that opposes the first end, the first end andthe second end being disconnected from each other, wherein the prolapseprevention device in a deployed configuration includes a centering ringconfigured to seat adjacent to and upstream of an annulus of the heartvalve to circumferentially center the prolapse prevention device insitu, wherein the centering ring is an open ring, an inner tail thatconforms to an inner surface of the centering ring and is configured topermit the open ring to self-adjust to a size of the annulus of theheart valve, a leaflet backstop extending radially inward from thecentering ring and configured to contact at least a first leaflet of theheart valve in situ to exert a pressure in a downstream direction on thefirst leaflet to prevent the first leaflet from prolapsing into theatrium, a vertical support extending from the centering ring in anupstream direction such that an apex thereof is configured to seatagainst a roof of an atrium in situ, and a retrieval arm extending fromthe apex of the vertical support in a downstream direction, away fromthe roof of the atrium.
 15. The prolapse prevention device of claim 14,wherein the prolapse prevention device is substantially straight in adelivery configuration.
 16. The prolapse prevention device of claim 14,wherein the leaflet backstop has a cross configuration with a first leg,a second leg, a first arm, and a second arm, the first leg and thesecond leg being parallel to each other and the first arm and the secondarm being parallel to each other, wherein the first leg and the secondleg extend perpendicular to the first arm and the second arm.
 17. Amethod of treating heart valvular regurgitation with a system includinga delivery catheter and a prolapse prevention device, the methodcomprising: percutaneously introducing the system into a vasculature;delivering the system through the vasculature to a heart valve with theprolapse prevention device in a delivery configuration, wherein theprolapse prevention device is formed by a continuous wire-like structurehaving a first end and a second end that opposes the first end, thefirst end and the second end being disconnected from each other, thecontinuous wire-like structure being substantially straight when theprolapse prevention device is in the delivery configuration; positioninga distal end of the delivery catheter adjacent to an annulus of theheart valve; and deploying the prolapse prevention device such that acentering ring of the continuous wire-like structure is seated adjacentto and upstream of the annulus of the heart valve, a vertical support ofthe continuous wire-like structure extends from the centering ring andan apex thereof is seated against a roof of the atrium, and a leafletbackstop of the continuous wire-like structure is extending radiallyinward from the centering ring and contacts at least a first leaflet ofthe heart valve to exert a pressure in a downstream direction on thefirst leaflet to prevent the first leaflet from prolapsing into theatrium.
 18. The method of claim 17, further comprising: percutaneouslyintroducing a valve delivery device into a vasculature, the valvedelivery device including a valve prosthesis disposed at a distal endthereof, wherein the valve prosthesis is in a compressed configurationand the step of percutaneously introducing a valve delivery device intoa vasculature is performed after the step of deploying the prolapseprevention device; delivering the valve delivery device through thevasculature to a heart valve; positioning the valve prosthesis in thecompressed configuration within the deployed prolapse prevention device;and deploying the valve prosthesis within the deployed prolapseprevention device.
 19. The method of claim 18, wherein the valveprosthesis is deployed within the leaflet backstop of the prolapseprevention device.
 20. The method of claim 18, wherein the valveprosthesis is deployed within the centering ring of the prolapseprevention device.